NDC 0536-1315 Cr-371059 Tolnaftate 1% Cream

Cr-371059 Tolnaftate 1% Cream

NDC Product Code 0536-1315

NDC CODE: 0536-1315

Proprietary Name: Cr-371059 Tolnaftate 1% Cream What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cr-371059 Tolnaftate 1% Cream What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Shape: FREEFORM (C48340)

NDC Code Structure

  • 0536 - Rugby Laboratories

NDC 0536-1315-43

Package Description: 1 g in 1 BOX

NDC Product Information

Cr-371059 Tolnaftate 1% Cream with NDC 0536-1315 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Cr-371059 Tolnaftate 1% Cream is cr-371059 tolnaftate 1% cream. The product's dosage form is cream and is administered via topical form.

Labeler Name: Rugby Laboratories

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Cr-371059 Tolnaftate 1% Cream Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TOLNAFTATE 1 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CETETH-20 (UNII: I835H2IHHX)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CHLOROCRESOL (UNII: 36W53O7109)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rugby Laboratories
Labeler Code: 0536
FDA Application Number: part333C What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Cr-371059 Tolnaftate 1% Cream Product Label Images

Cr-371059 Tolnaftate 1% Cream Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)• Helps prevent most athlete's foot with daily use• For effective relief of itching, burning, and cracking

Warnings


For External Use Only• This product is not effective on the scalp or nails

When Using This Product

Avoid contact with the eyes

Stop Use And Ask A Doctor If

• Irritation occurs• There is no improvement within 4 weeks

Keep Out Of Reach Of Children

• If swallowed, get medical help or contact a Poisen Control Center (1-800-222-1222) right away• Do not use on children under 2 years of age except under the advice and supervision of a doctor

Directions

• Wash affected area and dry thoroughly• Apply a thin layer over affected area twice daily (morning and night)• Supervise children in the use of this product• For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily• Use daily for 4 weeks; if condition persists longer, ask a doctor• To prevent athlete's foot, apply once or twice daily (morning and/or night)

Other Information

Store between 20° to 25ºC (68º to 77ºF)

Inactive Ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Sodium Phosphate Dihydrate, White Soft Paraffin (Petrolatum)

* Please review the disclaimer below.